ECHA

Despite increasing amounts of nanomaterials in products on the EU market, not enough is known about their hazards to adequately assess and control their risks. To bridge this knowledge gap, the REACH annexes that specify what information is required from companies placing chemicals on the market have been revised, legally obliging industry to also provide data for substances in nanoform. If adopted, the new changes will enter into force in January 2020. Jenny Holmqvist, ECHA’s coordinator for nanomaterials, shares her views on how companies can prepare.
 

Jenny Holmqvist. Image: ECHA.

What do the revised annexes change?

The implementation of REACH for nanomaterials has been challenging. This is because there is a general lack of information on the hazards of most nanomaterials as well as uncertainties on the applicability of test methods currently used to assess their properties.

There have also been differing opinions relating to the legal aspects of how information requirements should be fulfilled by industry and what exactly should be considered when carrying out a hazard assessment. These have related to, for example, how nanomaterials or nanoforms should be characterised under REACH.

The revised REACH annexes clarify the existing information requirements and introduce some new ones for companies registering nanoforms of their substances. By making the requirements explicit, implementing REACH will be easier and more efficient. Over time, these changes will also contribute to increasing knowledge on the hazards and risks of nanoforms of substances on the EU market.

A better understanding of the safety of nanomaterials will benefit consumers and workers, but will also help regulators identify whether further risk management measures are needed for specific uses or substances.

Who do the changes impact?

The changes are relevant for companies manufacturing or importing nanoforms of substances that fall within the scope of REACH. Nanoforms of substances are those covered by the European Commission’s recommendation for a definition of a nanomaterial.

It is important to point out that each nanomaterial can also exist in multiple forms depending on, for example, deliberate changes made to the surface of the particle.

Due to the various ways in which particles can be manipulated and thereby also characterised, I recommend that if you manufacture or import small particles, familiarise yourself, at the earliest opportunity, with the introduced changes to assess whether they are relevant for your substances

When will the new annexes come into force?

The draft Commission Regulation amending the annexes has not yet been formally adopted by the Commission. If adopted, industry will need to comply with the new requirements by January 2020. This might seem far away but this transitional period is needed for companies to not only assess if the changes apply to their substance, but also to conduct any necessary testing and further assessment.

What is ECHA doing to help companies prepare?

The positive vote among Member States in April 2018 to amend the annexes was also the starting point for us here at ECHA to prepare the necessary guidance to explain the changes to companies.

We are currently looking at which parts of the existing guidance need to be updated or whether new guidance is needed.

A significant part of this work is based on updated guidance that was already published in spring 2017.

Preparing guidance requires a significant amount of consultation where Member States, NGOs and industry are able to contribute. This is, and has been, an important way of working for us to ensure the developed guidance is balanced and based on the collective knowledge of all relevant parties. 

We also plan to increase our efforts in reaching out to industry organisations both in bilateral meetings and also through our guidance process. This way, we hope to ensure that there is sufficient support available for companies that are preparing possible updates to their registration dossiers.

Are there test methods already available to comply with the amended requirements?

Thanks to significant efforts in the research community, we know a lot more today about how to assess the risks of nanoforms of substances than we did 10 years ago.

Based on several research projects, many of which have been funded by the EU, we have also increased our knowledge of how some of the commonly used OECD test methods should be amended to better address the specificities of nanoforms.

The actual revision of these methods is not yet finalised. However, thanks to close collaboration among EU Member States, I expect this important work to speed up.

I would also like to stress that even though this work is ongoing, there are recognised protocols available for the vast majority of the amended requirements to help registrants comply with their legal obligations.

An important sign of progress took place in 2017 with the publication of the updated version of the test method for assessing inhalation toxicity, which is particularly relevant for nanoforms of substances.

Do the new information requirements imply that nanomaterials that are currently on the EU market are unsafe?

Already in 2012, as part of their second regulatory review of nanomaterials, the European Commission wrote that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures.

However, without changing the legal information requirements, it would be very difficult for authorities to verify whether companies registering their chemicals have demonstrated the safe use of nanomaterials throughout the supply chain or whether further regulatory actions for managing their risks would be needed.

I want to emphasise the word verify. I think we all agree that the realisation of the great opportunities that nanotechnology and nanomaterials may offer society should go hand-in-hand with the transparent demonstration by industry of their safety and sustainability.

Against this background, I welcome the amendments of the annexes and the legal clarifications they bring.

Did you know?    There is already available guidance on registering substances in nanoform to help you prepare for the revised information requirements:   Practical guide: How to prepare registration dossiers that cover nanoforms Guidance on grouping and read-across between nanoforms Nano-specific appendices to the guidance on information requirements and chemicals safety assessment

Further information:

European Union Observatory for Nanomaterials

ECHA's page on nanomaterials

ECHA's strategy on substances in nanoforms

European Commission: Amendments of the Annexes to REACH for registration of nanomaterials

European Commission: Definition of a nanomaterial

Interview by Adam Elwan

Published on: 13 September 2018
Updated on: 20 September 2018 to include an explicit reference that the adoption of the annexes has not yet taken place.

Top image: IStock/-Oxford-

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